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Vitamin D Reabsorption in Adolescents and Young Adults With HIV Infection

Primary Purpose

HIV Infections

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Vitamin D supplement
Placebo
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Vitamin D, Treatment Experienced

Eligibility Criteria

18 Years - 24 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 18 years and 0 days through 24 years and 364 days
  • HIV-1 infection as documented by any licensed ELISA test kit and confirmed by Western blot, HIV-1 culture, HIV-1 antigen, plasma HIV-1 RNA, or a second antibody test by a method other than ELISA at any time prior to study entry
  • Currently being treated with a stable FDA-approved ARV combination therapy, containing > 3 antiretrovirals, for > 28 days, according to HRSA guidelines. Treatment regimen will not be started or changed for the purposes of participation in this study. Subjects will be receiving therapy at the direction of their treating physician
  • Willingness to remain on the same ARV combination therapy for the 12-week duration of the study
  • Ability and willingness to participate in the study by providing written informed consent
  • Willingness to be randomized to receive either vitamin D or placebo

Exclusion Criteria:

  • Prior hypersensitivity to vitamin D
  • History of arteriosclerosis, renal stones, glomerulonephritis, nephrotic syndrome, or hypercalcemia
  • Lactation or current pregnancy
  • Active therapy for malignancy
  • Known presence of gastrointestinal disease that would interfere with drug administration or absorption
  • Serological evidence of Hepatitis B surface antigen (HBsAg)
  • Confirmed creatinine clearance < 90 ml/min (calculated GFR from serum creatinine using the MDRD formula)
  • Grade 3 or higher clinical toxicity

Sites / Locations

  • Children's Hopsital of Los Angeles
  • University of California at San Francisco
  • Children's National Medical Center
  • Children's Diagnostic and Treatment Center
  • University of Miami
  • University of South Florida
  • Stroger Hospital of Cook County
  • Childrens Memorial Hospital
  • Tulane University
  • University of Maryland Medical School
  • Montefiore Medical Center
  • Mount Sinai Hospital
  • Children's Hospital of Philadelphia
  • St. Jude Childrens Research Hospital
  • University of Puerto Rico

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

A: tenofovir/vitamin D

B: tenofovir/placebo

C: no tenofovir/vitamin D

D: no tenofovir/placebo

Arm Description

Vitamin D3 (cholecalciferol), 50,000 IU as a single capsule, will be administered orally to subjects in Group A (who are already taking Tenofovir) once every four weeks during study visits.

A placebo will be administered orally to subjects in Group B (who are already taking Tenofovir).

Vitamin D3 (cholecalciferol), 50,000 IU as a single capsule, will be administered orally to subjects in Group C (who are not taking Tenofovir) once every four weeks during study visits.

A placebo will be administered orally to subjects in Group D (who are not taking Tenofovir).

Outcomes

Primary Outcome Measures

To compare the change in renal tubular reabsorption of phosphate and markers of bone turnover.
To measure the safety of 50,000 IU dose of vitamin D3

Secondary Outcome Measures

To measure the relationship of vitamin D plasma concentrations to renal tubular reabsorption of phosphate and markers of bone turnover
To measure the relationship of tenofovir exposure to renal tubular reabsorption of phosphate and markers of bone turnover
To measure the change in tenofovir exposure and creatinine clearance

Full Information

First Posted
June 21, 2007
Last Updated
February 27, 2017
Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Institute on Drug Abuse (NIDA), National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00490412
Brief Title
Vitamin D Reabsorption in Adolescents and Young Adults With HIV Infection
Official Title
Randomized, Placebo-controlled Trial of the Safety and Effectiveness of Vitamin D Supplement to Improve Tubular Reabsorption of Phosphate and Decrease Bone Turnover in Adolescents and Young Adults With HIV Infection Being Treated With Antiretroviral Therapy Containing Tenofovir Compared to Those Being Treated With Antiretroviral Therapy Not Containing Tenofovir
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Institute on Drug Abuse (NIDA), National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to test the effects of Vitamin D on renal phosphate and bone loss, which are common in HIV infected adolescents and young adults being treated with tenofovir.
Detailed Description
ATN 063 tests the hypothesis that in a population of adolescents and young adults with HIV infection who are being treated with tenofovir as part of an antiretroviral (ARV) combination regimen, vitamin D supplementation will decrease renal phosphate loss, increase plasma phosphate, decrease plasma PTH, and improve markers of bone turnover, including a decrease in plasma N-telopeptide and BAP.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Vitamin D, Treatment Experienced

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
207 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A: tenofovir/vitamin D
Arm Type
Experimental
Arm Description
Vitamin D3 (cholecalciferol), 50,000 IU as a single capsule, will be administered orally to subjects in Group A (who are already taking Tenofovir) once every four weeks during study visits.
Arm Title
B: tenofovir/placebo
Arm Type
Placebo Comparator
Arm Description
A placebo will be administered orally to subjects in Group B (who are already taking Tenofovir).
Arm Title
C: no tenofovir/vitamin D
Arm Type
Experimental
Arm Description
Vitamin D3 (cholecalciferol), 50,000 IU as a single capsule, will be administered orally to subjects in Group C (who are not taking Tenofovir) once every four weeks during study visits.
Arm Title
D: no tenofovir/placebo
Arm Type
Placebo Comparator
Arm Description
A placebo will be administered orally to subjects in Group D (who are not taking Tenofovir).
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D supplement
Intervention Description
Vitamin D3 (cholecalciferol), 50,000 IU as a single capsule, will be administered orally to subjects in Groups A and C once every four weeks during study visits.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
A placebo will be administered orally to subjects in Groups B and D once every four weeks during study visits.
Primary Outcome Measure Information:
Title
To compare the change in renal tubular reabsorption of phosphate and markers of bone turnover.
Time Frame
Baseline, Week 4, Week 12
Title
To measure the safety of 50,000 IU dose of vitamin D3
Time Frame
Baseline, Week 4, and Week 8
Secondary Outcome Measure Information:
Title
To measure the relationship of vitamin D plasma concentrations to renal tubular reabsorption of phosphate and markers of bone turnover
Time Frame
Baseline, Week 4, and Week 12
Title
To measure the relationship of tenofovir exposure to renal tubular reabsorption of phosphate and markers of bone turnover
Time Frame
Baseline, Week 4, and Week 12
Title
To measure the change in tenofovir exposure and creatinine clearance
Time Frame
Baseline, Week 4, and Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18 years and 0 days through 24 years and 364 days HIV-1 infection as documented by any licensed ELISA test kit and confirmed by Western blot, HIV-1 culture, HIV-1 antigen, plasma HIV-1 RNA, or a second antibody test by a method other than ELISA at any time prior to study entry Currently being treated with a stable FDA-approved ARV combination therapy, containing > 3 antiretrovirals, for > 28 days, according to HRSA guidelines. Treatment regimen will not be started or changed for the purposes of participation in this study. Subjects will be receiving therapy at the direction of their treating physician Willingness to remain on the same ARV combination therapy for the 12-week duration of the study Ability and willingness to participate in the study by providing written informed consent Willingness to be randomized to receive either vitamin D or placebo Exclusion Criteria: Prior hypersensitivity to vitamin D History of arteriosclerosis, renal stones, glomerulonephritis, nephrotic syndrome, or hypercalcemia Lactation or current pregnancy Active therapy for malignancy Known presence of gastrointestinal disease that would interfere with drug administration or absorption Serological evidence of Hepatitis B surface antigen (HBsAg) Confirmed creatinine clearance < 90 ml/min (calculated GFR from serum creatinine using the MDRD formula) Grade 3 or higher clinical toxicity
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter L Havens, M.S., M.D.
Organizational Affiliation
Medical College of Wisconsin
Official's Role
Study Chair
Facility Information:
Facility Name
Children's Hopsital of Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
University of California at San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Children's National Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Children's Diagnostic and Treatment Center
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33316
Country
United States
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33101
Country
United States
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Stroger Hospital of Cook County
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Childrens Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60614
Country
United States
Facility Name
Tulane University
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
University of Maryland Medical School
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Mount Sinai Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10128
Country
United States
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
St. Jude Childrens Research Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38105
Country
United States
Facility Name
University of Puerto Rico
City
San Juan
ZIP/Postal Code
00936
Country
Puerto Rico

12. IPD Sharing Statement

Citations:
PubMed Identifier
24535626
Citation
Havens PL, Hazra R, Stephensen CB, Kiser JJ, Flynn PM, Wilson CM, Rutledge B, Bethel J, Pan CG, Woodhouse LR, Van Loan MD, Liu N, Lujan-Zilbermann J, Baker A, Kapogiannis BG, Gordon CM, Mulligan K; Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN) 063 study team. Vitamin D3 supplementation increases fibroblast growth factor-23 in HIV-infected youths treated with tenofovir disoproxil fumarate. Antivir Ther. 2014;19(6):613-8. doi: 10.3851/IMP2755. Epub 2014 Feb 17.
Results Reference
derived
PubMed Identifier
24002093
Citation
Havens PL, Kiser JJ, Stephensen CB, Hazra R, Flynn PM, Wilson CM, Rutledge B, Bethel J, Pan CG, Woodhouse LR, Van Loan MD, Liu N, Lujan-Zilbermann J, Baker A, Kapogiannis BG, Gordon CM, Mulligan K; Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN) 063 Study Team. Association of higher plasma vitamin D binding protein and lower free calcitriol levels with tenofovir disoproxil fumarate use and plasma and intracellular tenofovir pharmacokinetics: cause of a functional vitamin D deficiency? Antimicrob Agents Chemother. 2013 Nov;57(11):5619-28. doi: 10.1128/AAC.01096-13. Epub 2013 Sep 3.
Results Reference
derived
PubMed Identifier
22267714
Citation
Havens PL, Stephensen CB, Hazra R, Flynn PM, Wilson CM, Rutledge B, Bethel J, Pan CG, Woodhouse LR, Van Loan MD, Liu N, Lujan-Zilbermann J, Baker A, Kapogiannis BG, Mulligan K; Adolescent Medicine Trials Network (ATN) for HIV/AIDS Interventions 063 study team. Vitamin D3 decreases parathyroid hormone in HIV-infected youth being treated with tenofovir: a randomized, placebo-controlled trial. Clin Infect Dis. 2012 Apr;54(7):1013-25. doi: 10.1093/cid/cir968. Epub 2012 Jan 19.
Results Reference
derived

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Vitamin D Reabsorption in Adolescents and Young Adults With HIV Infection

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